Rejuvenated RBC and VO2 Max in Healthy Subjects

PHASE4TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

September 29, 2017

Primary Completion Date

April 18, 2018

Study Completion Date

April 18, 2018

Conditions
Erythrocyte Transfusion
Interventions
BIOLOGICAL

Transfusion of rejuvenated and washed autolgous RBCs

Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.

BIOLOGICAL

Transfusion of washed autolgous RBCs

Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm

Trial Locations (1)

27514

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Zimmer Biomet

INDUSTRY

lead

Duke University

OTHER